Pauwels Consulting assists companies in Belgium and abroad in setting up and monitoring quality

systems and continuously improving business processes. We have a number of experienced ISO
9001 consultants on board to achieve this.

Luc Marivoet is one of our quality experts. We interviewed Luc about the publication of the new
ISO 9001:2015 standard and the main differences between ISO 9001:2015 and ISO 9001:2008.

Luc, can you tell us a little bit about yourself?

Luc: I’m Luc Marivoet, Senior Engineering
Consultant. I’ve been working at Pauwels
Consulting since January 2013 and I have
twenty-five years’ experience of applying
quality management systems.

After my studies as a technical engineer, I

worked successively as a Quality Test
Engineer, Quality Control Manager, Quality
Auditor and Quality Manager in various sectors.

At the moment, I am working as an ISO Quality Manager for the service Signalling Projects at
Infrabel, the organisation that manages the Belgian rail network’s infrastructure. I am responsible
for setting up, implementing, monitoring and maintaining the ISO 9001 certified quality
management system.

What is ISO 9001 again?

Luc: ISO 9001 is the world’s most popular and most commonly used standard for quality
management systems.

A standard is not a law, but an agreement or best practice that an organisation can apply
voluntarily. A standard reflects a good level of professionalism. A quality management system is
a tool with which an organisation can determine how it can meet the requirements of its customers
and the other interested parties that are involved in its activities.

What are the benefits of ISO 9001?

Luc: An ISO 9001 quality management system:
 shows that you provide products and services of consistent quality;
 shows that you provide products and services that meet the customer’s requirements,
comply with the law and legislation, and meet the organisation’s own requirements;
 Can help you streamline your business processes and continuously improve them.

There are two additional benefits:

 ISO 9001 helps you increase customer satisfaction;

 ISO 9001 is positive for your image: you show that you comply with internationally
recognised quality standards. This is often a requirement for customers and suppliers to do
business with you.
What does the ISO 9001 standard specify?

The most recent ISO 9001:2015 standard is constructed around seven quality management
principles:

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 1. customer focus;
2. leadership;
3. engagement of people;
4. process approach;
5. improvement;
6. evidence-based decision making;
7. Relationship management.

ISO 9001:2015 describes for each part which requirements your products, services and
organisation have to meet in order to enjoy the above benefits.

Who determines, checks and manages ISO 9001?

ISO 9001 is managed by the International Organisation for Standardisation (ISO) in Geneva,
Switzerland. ISO is an independent membership organisation and the world’s largest developer
of voluntary international standards. ISO 9001:2015 was developed by the ISO / TC 176 / SC 2 –
Quality Systems Technical Committee.

However, ISO does not provide certification or conformity assessment. This is performed by
accredited certification bodies. These are establishments that evaluate an organisation’s
management system and certify them with respect to the published standards.

I understand that the previous version of ISO 9001 dates from 2008 and that there is now a new
version?

That’s right. A new version of ISO 9001 appears about every seven years.

It was first issued in 1987: at that time, you had to describe in detail what your business did. What
applied in the 1994 version, was ‘say what you do and do what you say’. In the 2000 version, you
had to focus on proper processes in order to continually improve and thereby increase your
customer satisfaction. There was nothing added in 2008, but it was more precise about the
interpretation of the standard. ISO 9001:2015 was published on 23 September 2015.

Do organisations have to move over from ISO 9001:2008 to ISO 9001:2015 immediately?

No. There is a transitional period of three years after the publication of each new version of ISO
9001, during which organisations can adapt their quality management to match the latest version.
Organisations must therefore implement the new ISO 9001:2015 standard before 23 September
2018 in order to continue complying with ISO 9001.

What are the main differences between ISO 9001:2008 and ISO 9001:2015?
ISO 9001:2015 HAS TEN CLAUSES INSTEAD OF EIGHT

ISO 9001:2015 has ten clauses instead of eight. The following table shows the relationship of the
ISO 9001:2008 clauses to those in the new ISO 9001:2015.

I SO 9 00 1: 20 08 I SO 9 00 1: 20 15

0. Introduction 0. Introduction
1. Scope 1. Scope
2. Normative reference 2. Normative reference

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 3. Terms and definitions 3. Terms and definitions
4. Quality management system 4. Context of the organisation
5. Leadership
5. Management responsibility
6. Planning
6. Resource management 7. Support
7. Product realisation 8. Operation
9. Performance evaluation
8. Measurement, analysis and improvement
10. Improvement

The first three clauses in ISO 9001:2015 are largely the same as those in ISO 9001:2008, but
there are considerable differences between ISO 9001:2008 and ISO 9001:2015 from the fourth
clause onwards. The last seven clauses are now arranged according to the PDCA cycle (Plan,
Do, Check, Act). The following figure shows this.

Clauses 4, 5, 6 and 7 of ISO 9001:2015 come under PLAN, clause 8 comes under DO, clause 9
comes under CHECK and clause 10 is covered by ACT.

With this new arrangement, the new ISO 9001:2015 strives to give additional momentum to the
continuous and systematic improvement of processes within organisations.

ISO 9001:2015 HAS A HIGH LEVEL STRUCTURE (HLS)

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As a result of the new arrangement in ten clauses, ISO 9001:2015 now has the same
unambiguous structure as all standardised management systems, known as a ‘High Level
Structure’ (HLS).

The core elements of ISO 9001,

ISO 14001, ISO 22000,

OHSAS 18001, etc. are

therefore all the same from now
on. This has made the
integration of various
management systems much
simpler. If, for example, an
organisation wishes to
implement ISO 14001 in
addition to ISO 9001, the parts
that cover the same topic can
easily be seen in the standards.

ISO 9001:2015 PUTS MORE FOCUS ON INPUT AND OUTPUT

There is more emphasis in ISO 9001:2015 on measuring and properly assessing the input and
output of processes. According to ISO 9001:2015, you must closely monitor which articles,
information and specifications are involved in the production process. You must also clearly check
whether good articles come out of the production process.

RISK-BASED THINKING IS AT THE CORE OF ISO 9001:2015

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Risk-based thinking has a very important place in ISO 9001:2015. You are now strongly
encouraged as an organisation to use risk analysis in order to decide for yourself which challenges
you see in the management of your business processes.

Formal risk analysis, familiar to many organisations via FMEA or HACCP techniques, is now
standard for everyone. To emphasise their dominance, the concept of ’risk’ occurs forty-eight
times in ISO 9001:2015, compared with only three times in ISO 9001:2008.

The addition of risk-based thinking has made the ‘preventive measures’ of ISO 9001:2008
redundant. These preventive measures no longer appear in ISO 9001:2015.

CONTEXT OF THE ORGANISATION IMPORTANT IN ISO 9001:2015

ISO 9001:2015 requires an organisation to construct its quality management system from now on
from the specific context within which it is active. This means, among other things, that, as an
organisation, you have to take into account the needs and expectations of interested parties and
that you evaluate and deal with internal and external strategic questions. You have to show that,
as an organisation, you understand and respond to the expectations of all the parties concerned.

ISO 9001:2015 AND THE ENGAGEMENT OF INTERESTED PARTIES

In ISO 9001:2008, customers were often named as being the only interested party. This concept
has been extended in ISO 9001:2015. Suppliers, personnel, shareholders, legislative bodies,
society, internal customers, etc. are now included as interested parties, in addition to customers.

As an organisation, you have to be aware of the importance of these interested parties’ (changing)
requirements and standards, and anticipate them in the features of your products and services.

This has always been part of the standard in another form, however. Therefore, it is not expected
that organisations will have to implement major changes in this respect. You cannot make or
deliver a good product without knowing the requirements and expectations of customers and
interested parties in any case. This is the basis of a quality management system.

LEADERSHIP AND COMMITMENT IN ISO 9001:2015

ISO 9001:2015 also places more emphasis on leadership and management commitment. It
requires greater involvement by top managers and business leaders in controlling the quality
management system.

This way, ISO 9001:2015 is intended to encourage integration and harmonisation with business
processes and business strategies. The top management now has to take more responsibility for
the effectiveness of the quality management system.

Because ISO 9001:2015 pays more attention to risk management, interested parties and the
context of the organisation, the quality management system also fits in better with the needs of
the top management.

The quality management system is now more than ever a means for being strategically successful
by addressing the needs of interested parties and by managing opportunities and threats.

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The ‘management representative’ of ISO 9001:2008 was a member of the management
committee who had the responsibility and authority for steering the quality management system
along the right lines. ISO 9001:2015 does not mention this aspect any more. The idea behind the
change is that quality is a matter for everyone and for all levels within the organisation.

DOCUMENTED INFORMATION

ISO 9001:2015 no longer requires obligatory documented procedures or a quality manual. This
is noteworthy. This is now referred to as ‘documented information’ in practically all clauses of ISO
9001:2015.

The definition states that it concerns ‘information that the organisation has to control and
maintain’. The information can be in any format and come from various sources and media.
Diverse forms of evidence or documentation are therefore possible.

There is no longer any mention of ‘records’ neither, but of ‘retaining documented information’.

DIFFERENT TERMINOLOGY IN ISO 9001:2008 AND ISO 9001:2015

The following table is a brief summary of a number of important changes to the terminology
compared with ISO 9001:2008.

I SO 9 00 1: 20 08 I SO 9 00 1: 20 15

Products Products and services

Documentation, quality manual, documented
Documented information
procedures, records, instructions
Environment for the operation of
Work environment
processes
Monitoring and measuring
Monitoring and measuring equipment
resources
Externally provided products
Purchased product
and services
Supplier External provider

This is not an exhaustive list of the differences between ISO 9001:2008 and ISO 9001:2015, but
it does show the main points.

How can companies transition from ISO 9001:2008 to ISO 9001:2015?

Assuming that a company is already ISO 9001 certified, I recommend taking the following steps
in order to comply with ISO 9001:2015:

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1. Baseline measurement
Perform a baseline measurement in your organisation. Make a complete overview of the current
status of your quality management system and your organisation’s conduct of business.
2. Plan of approach
Draw up a plan based on the baseline measurement. Thanks to this plan, you can take the time
to make changes and to implement improvements step by step.
3. Implementation
Implement the changes in accordance with the plan of approach. Incorporate measurement points
and milestones.
4. Auditing and process analysis
Measure whether the changes have had the desired effect. Measure the input and output of the
processes you consider to be important because they are critical or risky, for example.
5. Certification
Have your organisation certified according to ISO 9001:2015.
6. Communication with interested parties
Show your interested parties not just the certificate, but also show them the results with pride. Let
them see how well your organisation manages its processes and continuously improves them.
Is there anything else companies need to know before they get going with ISO 9001 or the new
version ISO 9001:2015?

The requirement for formal procedures and a quality

manual have been scrapped in ISO 9001:2015, as was
stated above. Only relevant information has to be
available now.

Organisations that already have an ISO 9001 quality

management system do not have to discard their
existing procedures and documentation, of course. A
good system remains a good system and you will still
need a proper structure for your crucial documentation.

If something is no longer obligatory, it doesn’t mean that

you have to scrap it right away, of course. It’s better to
hang on to what you are happy with and what helps your
organisation to progress.

Thank you for this interesting conversation, Luc.

QUESTIONS OR MORE INFORMATION?
Do you have any questions about quality systems, ISO 9001, ISO 9001:2015 or the transition
from ISO 9001:2008? Then contact us without obligation on +32 9 324 70 80 or
at contact@pauwelsconsulting.com. We will be pleased to help you!

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